Gene therapy is going viral
Over de functie
Yacht Life Sciences has a vacancy for a Laboratory Technician Analytical Development - Phase I-II.
Our client's gene therapeutic vectors are complex biological products that are subject to extensive quality testing before they are released for purpose. As a Technician Analytical Development – Phase I-II Assay Development, you will be responsible for developing and assay transfer of analytical methods to support quality testing of gene therapy products up to, and including, the Phase I/II clinical stage.
The function specifically entails proper planning and performance for the development of assays for Research and Development and QC, to allow characterization and release of products for non-clinical and clinical use. Furthermore, as a Technician you support the routine analytical testing of the PD support group for AAV based intermediates and products and the assay transfer to AD Lexington and QC.
Overall, as a Technician Analytical Development – Phase I-II Assay Development, you should have affinity with planning as well as with (bio-) analytics, will train PD-dedicated analytical staff, and reports to the Phase I-II Assay Development Lead within AD.
Key result areas:
- Planning and performance of the development and qualification of (bio)assays to allow characterization and release of products for non-clinical and clinical use of gene therapeutic vectors
- Support assay transfer (for R&D purposes- to other departments in AMS; or for implementation into GMP- to AD/QC at a manufacturing site in the USA)
- Support routine testing (biological assays and physical/chemical testing) using pre-established methods on samples generated during process development
- Timely and adequately reporting of analytical results within the Analytical Development team, reporting of and assay development (in the form of AIMs), support in reporting.
- Educating and supporting other lab members, supervise analysis and ensure quality of reported data
- Participation in troubleshooting and new technologies development
As a Technician Analytical Development, you have/are:
- BSc/ MSc/ PhD in a Life Sciences-related field (biochemistry, molecular biology, biotechnology)
- At least 2 years of relevant working experience in a comparable position (similar type of work, similar group dynamics), preferentially in an industrial organization
- Knowledge in relevant scientific field required
- Strong experience in molecular biology techniques (plasmid purification and analysis, PCR, QPCR, DNA electrophoresis, primer design, DNA sequence analysis, western blotting), cellular biology techniques (culturing of insect and human cells) and biochemical analyses
- Experience in assay development and qualification, preferably in the area of biopharmaceuticals, gene therapy vectors and/or vaccines
- Fluency in English, written and verbal communication skills
- Integer: accurate, organized, dependable, proactive, motivated, flexible
- Thorough: ability to carry out tasks with an eye for completeness (e.g. results achieved according to agreed AIMs and/or protocols, results discussed with team members, issues identified and resolved
- Planning and organizing: Effective time-management skills with ability to meet deadlines, ability to plan and execute own workload, with some guidance where needed
- Detail-oriented: analytical mind set, ability to pick up on important details
- Problem solving: ability to identify problems (assay performance, equipment, or test results), discuss these within the team, and to find a solution
- Taking initiative: signals problems, recognizes important information, traces possible causes of problems, thinks about and implements new working methods or new applications
- Co-operative: ability to work within a team and with other teams to drive projects forward according to agreed time-lines
This concerns a temporary position (maternity leave cover) for 7 months at our client, but a 1 year contract will be given by Yacht if appointed for this role. We will offer a competitive benefits package in line with the seniority of the position. You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers and will be able to follow courses and training via our Yacht Academy and keep your knowledge and skills up-to-date: boosting your career through personal and scientific growth.
Our client is dedicated to bringing therapies for unmet medical needs to patients. In doing so each function is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working life (i) by living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.
Analytical Development is covering important areas in generating value of AAV-based products. First, the department is responsible for developing, qualifying and implementing product specific assays to ensure the quality of their products, and to monitor analytical method performance and provide continued analytical support during routine testing. Such analytical development also includes extended product characterization, generating and qualifying (early) reference standards, spec setting. Second, the department is responsible for the analysis of samples coming from manufacturing campaigns for R&D products and generating data that is subsequently used to qualify product used for preclinical/ nonclinical testing or used to make decisions in process development. Further, the department develops and implements assays to monitor function and safety of its products during clinical development and beyond MAA. Finally, the department is responsible for formulation development, and performing drug product characterization, (early) stability assessment, and compatibility assessment.
Phase I-II Assay Development is responsible for developing and implementing product specific assays to ensure the quality of the products. Those activities are supporting the whole scope of AAV product development, especially Process-, Non-clinical and Clinical development. The group is responsible for proper transfer of assays and know-how to AD Lexington and the Quality Control Department.
Phase I-II Assay development also has to ensure that assays to be developed and implemented meet the appropriate legislation and follow internal quality standards. This requires active interaction with the Regulatory and the Quality Assurance departments.
Voor meer informatie neem je contact op met Edwin Parlevliet via telefoonnummer +31(6)12387998
Werken voor Yacht
Yacht is dé organisatie van en voor professionals. Wij verbinden professionals en organisaties die het verschil willen maken. Ons doel is optimaal resultaat: jou als professional uitdagend werk bieden waarmee jij de organisaties van onze opdrachtgevers blijvend verbetert. Behoor jij tot de beste professionals in jouw vak? Wil je samen met vakgenoten het verschil maken bij toonaangevende organisaties? Dan willen we jou graag leren kennen.
Uiteraard staat deze vacature open voor zowel mannen als vrouwen.